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Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness

Primary Purpose

Depression, Anxiety, Inflammatory Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based Cognitive Behavioral Therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring anxiety, depression, chronic illness, teen, young adult

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of chronic illness
  • Language: English
  • Computer and Internet access
  • Symptoms of mild-moderate depression and/or anxiety

Exclusion Criteria:

  • Existing mental health diagnosis
  • Psychoactive medications initiated in past 2 months
  • Severe depression
  • Suicidal ideation (refer to on-call psychiatrist and/or social worker for urgent intervention) or history of prior suicide attempt

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Web-based Cognitive Behavioral Therapy

    Arm Description

    Participants will be directed to a web-based CBT "self-help" program with weekly modules.

    Outcomes

    Primary Outcome Measures

    Program completion rates
    Intervention completion rates will be used as a marker for acceptability of the intervention.

    Secondary Outcome Measures

    Change in pre-and post-intervention score on measure of depression (PHQ-9)
    Change in pre-and post-intervention score on measure of anxiety (GAD-7)
    Change in pre-and post-intervention score on measure of quality of life (Peds-QL)
    Change in pre-and post-intervention score on measure of patient activation (PAM)

    Full Information

    First Posted
    May 19, 2015
    Last Updated
    April 25, 2016
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02453880
    Brief Title
    Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness
    Official Title
    Web-based "Self-Help" Cognitive Behavioral Therapy for Symptoms of Mild-to-Moderate Anxiety and Depression in Adolescents and Young Adults With Chronic Illness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Symptoms of anxiety and depression are common in adolescents and young adults with chronic illnesses and are associated with decreased adherence to medical regimens. However, many young patients go untreated for anxiety and depression. The purpose of this study is to evaluate an online cognitive behavioral therapy (CBT) program in young adults with chronic illness. Prior research has shown online CBT to be effective in multiple other populations, but to the investigators' knowledge, this is the first study to examine web-based CBT for young adults with chronic illnesses.
    Detailed Description
    Emotional problems such as anxiety and depression commonly surface during adolescence and are even more common among youth with chronic illness compared to other children. Emotional comorbidities are associated with decreased adherence to medical regimens in children and adults as well as poorer clinical outcomes for medical conditions and increased medical expenditures. It is widely accepted that cognitive behavioral therapy is an effective treatment for anxiety and depression and in-person CBT has been shown effective for young people with inflammatory bowel disease (IBD). However, despite the presence of this effective treatment, the majority of those with anxiety and depression are untreated. Offering mental health services in an acceptable, feasible and low cost fashion remains a challenge. Research suggests that web-based CBT is a promising candidate for offering effective and feasible treatment for anxiety and depression to young people. It has been shown effective for mild to moderate symptoms of depression and anxiety in adults and adolescents with a primary diagnosis of depression. In adults, studies comparing face-to-face CBT treatment to web-based CBT with low level therapist support showed comparable clinical outcomes and a 15% cost savings for online treatment. Furthermore, an online treatment format may be especially appealing for younger populations who spend much of their time online as well as for people with chronic illness, who may be home-bound due to symptoms. Despite the well-established evidence base for web-based CBT in other populations, the greater affordability of web-based CBT compared to face-to-face treatment, and the appeal of the online format for young adults, the investigators are aware of no published studies examining the use of web-based CBT for young adults with chronic illness. The innovation of the proposed project is to study low- cost, web-based CBT in a new population of adolescents and young adults with inflammatory conditions that constitute serious chronic illness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety, Inflammatory Bowel Disease, Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis
    Keywords
    anxiety, depression, chronic illness, teen, young adult

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Web-based Cognitive Behavioral Therapy
    Arm Type
    Experimental
    Arm Description
    Participants will be directed to a web-based CBT "self-help" program with weekly modules.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Web-based Cognitive Behavioral Therapy
    Intervention Description
    Participants will be asked to complete a web-based cognitive behavioral therapy "self-help" program. The program consists of six weekly modules, in which participants practice new ways of thinking (e.g. how to recognize and change distorted thinking, utilizing a thought change record, identifying cognitive errors, and modifying automatic thoughts) to reduce symptoms of anxiety and depression. Participants receive text message reminders to complete the weekly session.
    Primary Outcome Measure Information:
    Title
    Program completion rates
    Description
    Intervention completion rates will be used as a marker for acceptability of the intervention.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in pre-and post-intervention score on measure of depression (PHQ-9)
    Time Frame
    Baseline and 3 months
    Title
    Change in pre-and post-intervention score on measure of anxiety (GAD-7)
    Time Frame
    Baseline and 3 months
    Title
    Change in pre-and post-intervention score on measure of quality of life (Peds-QL)
    Time Frame
    Baseline and 3 months
    Title
    Change in pre-and post-intervention score on measure of patient activation (PAM)
    Time Frame
    Baseline and 3 months
    Other Pre-specified Outcome Measures:
    Title
    Program satisfaction survey
    Description
    Satisfaction with the web-based program will be assessed with a survey 3 months after enrollment in the study.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of chronic illness Language: English Computer and Internet access Symptoms of mild-moderate depression and/or anxiety Exclusion Criteria: Existing mental health diagnosis Psychoactive medications initiated in past 2 months Severe depression Suicidal ideation (refer to on-call psychiatrist and/or social worker for urgent intervention) or history of prior suicide attempt

    12. IPD Sharing Statement

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    Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness

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